CTRI/2011/05/001721已完成Unknown
EVALUATION AND COMPARISON OF ANTI-ACNE TEST PRODUCTS ON MILD TO MODERATE ACNE
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Evaluation of inflammatory acne count.
研究概览
简要总结
Trial has been started .
This is a test under dermatological control, multicentric, double blinded, randomized, comparative – versus initial state, and between groups.
At Visit 1, baseline inflammatory acne count and digital photographs were taken. Baseline dermatological scoring was done.
Dermatological evaluation for cutaneous tolerance was done by a Dermatologist. Inflammatory acne count and digital photographs were taken at all visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Voluntary men/women with inflammatory acne lesions (
- •on entire face. 2.Age between 18 – 55 yr 3.No treatment for acne in the past 1 month 4.Phototype III and IV. 5.All skin types (greasy, normal) except sensitive skin. 6.Accepting not to use products with the same end benefit during the entire study duration. 7.For whom the Investigator considers that the compliance will be correct. 8.Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 9.Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.
排除标准
- •1.Pregnant women (as confirmed by UPT) and lactating women.
- •2.History suggestive of any hormonal problems.
- •3.History of allergic dermatitis or contact allergy to cosmetics, 4.Subjects on oral retinoid in the past 3 months.
- •5.Hypersensitivity to any cosmetic product, raw material.
- •6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
- •7.Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month).
- •8.Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial.
结局指标
主要结局
Evaluation of inflammatory acne count.
时间窗: Visit 1 (Day 0), Visit 2 (1 week), Visit 3 (2 weeks), Visit 4 (4 weeks), Visit 5 (6 weeks), Visit 6 (8 weeks), Visit 7 (10 weeks), Visit 8 (12 weeks).
次要结局
- Dermatological evaluation of cutaneous tolerance.(Visit 1 (Day 0), Visit 2 (1 week), Visit 3 (2 weeks), Visit 4 (4 weeks), Visit 5 (6 weeks), Visit 6 (8 weeks), Visit 7 (10 weeks), Visit 8 (12 weeks).)
研究者
研究点 (2)
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